de Jager Rosa L, de Beus Esther, Beeftink Martine M A, Sanders Margreet F, Vonken Evert-Jan, Voskuil Michiel, van Maarseveen Erik M, Bots Michiel L, Blankestijn Peter J
From the Department of Nephrology and Hypertension (R.L.d.J., E.d.B., M.F.S., P.J.B.), Department of Cardiology (M.M.A.B., M.V.), Department of Radiology (E.-J.V.), Department of Clinical Pharmacy (E.M.v.M.), and Julius Center for Health Sciences and Primary Care (M.L.B.), University Medical Center Utrecht, The Netherlands.
Hypertension. 2017 Apr;69(4):678-684. doi: 10.1161/HYPERTENSIONAHA.116.08818.
Randomized trials of catheter-based renal denervation (RDN) as therapy for resistant hypertension showed conflicting results in blood pressure (BP) lowering effect. Adherence to medication is modest in this patient group and may importantly drive these conflicting results. SYMPATHY is a prospective open label multicenter trial in Dutch patients with resistant hypertension. Primary outcome was change in daytime systolic ambulatory BP at 6 months. Patients were randomly assigned to RDN on top of usual care. Adherence to BP lowering drugs was assessed at baseline and follow-up, using blood samples drawn synchronously with BP measurements. Patients and physicians were unaware of the adherence assessment. Primary analyses showed a mean difference between RDN (n=95) and control (n=44) in changes in daytime systolic ambulatory BP after 6 months of 2.0 mm Hg (95% confidence interval, -6.1 to 10.2 mm Hg) in favor of control. In 80% of patients, fewer medications were detected than prescribed and adherence changed during follow-up in 31%. In those with stable adherence during follow-up, mean difference between RDN and control for daytime systolic ambulatory BP was -3.3 mm Hg (-13.7 to 7.2 mm Hg) in favor of RDN. RDN as therapy for resistant hypertension was not superior to usual care. Objective assessment of medication use shows that medication adherence is extremely poor, when patients are unaware of monitoring. Changes over time in adherence are common and affect treatment estimates considerably. Objective measurement of medication adherence during follow-up is strongly recommended in randomized trials.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01850901.
基于导管的肾去神经支配术（RDN）治疗顽固性高血压的随机试验在血压降低效果方面显示出相互矛盾的结果。该患者群体的药物依从性一般，这可能是导致这些矛盾结果的重要原因。SYMPATHY是一项针对荷兰顽固性高血压患者的前瞻性开放标签多中心试验。主要结局是6个月时日间收缩期动态血压的变化。患者被随机分配接受RDN联合常规治疗。在基线和随访时，使用与血压测量同步采集的血样评估降压药物的依从性。患者和医生并不知晓依从性评估情况。初步分析显示，6个月后，RDN组（n = 95）和对照组（n = 44）日间收缩期动态血压变化的平均差值为2.0 mmHg（95%置信区间，-6.1至10.2 mmHg），有利于对照组。在80%的患者中，检测到的药物少于处方量，31%的患者在随访期间依从性发生了变化。在随访期间依从性稳定的患者中，RDN组和对照组日间收缩期动态血压的平均差值为-3.3 mmHg（-13.7至7.2 mmHg），有利于RDN组。RDN作为顽固性高血压的治疗方法并不优于常规治疗。对药物使用的客观评估表明，当患者不知道被监测时，药物依从性极差。依从性随时间的变化很常见，并且对治疗评估有很大影响。在随机试验中强烈建议在随访期间对药物依从性进行客观测量。
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